Effect of Massage Therapy on Severity of Restless Legs Syndrome and Quality of Life in Hemodialysis Patients
- Conditions
- Hemodialysis
- Interventions
- Behavioral: massage therapy with lavender oilBehavioral: massage therapy with baby oil
- Registration Number
- NCT04630470
- Lead Sponsor
- TC Erciyes University
- Brief Summary
The restless leg syndrome (RLS) is among the most common problems for the individuals undergoing hemodialysis (HD) therapy. This randomized controlled trial was conducted to determine the effect of the massage, applied with 5% lavender oil for the individuals receiving HD therapy, in the first half of HD session three times a week for four weeks on both legs for 10 minutes in each leg, on severity of RLS and quality of life. The study was completed with 58 patients including 31 people in the intervention group and 27 people in the placebo control group, in 7 hemodialysis centers located in a city center. The ethics committee approval, informed consent of the individuals and the institutional permission were obtained. The data were collected using the patient information form, RLS Severity Rating Scale, Kidney Disease Quality of Life Questionnaire (KDQOLTM-36) and patient follow-up charts. In accordance with the massage application protocol, those in the intervention group were massaged with lavender oil and those in the placebo group were massaged with baby oil. Chi-square test, t test, repeated measures one-way analysis of variance, and Pearson correlation analysis tests were used to assess the data. In the comparisons, the value of p\<0.05 was accepted as significant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- Patients aged ≥18 years
- were not pregnant or did not plan pregnancy
- were diagnosed with RLS by a physician
- had at least mild RLS based on the RLS Severity Rating Scale
- had received HD treatment in the HD units for at least 3 months and three sessions per week
- had continued the dialysis treatment at the same institution
- had not changed the treatment schedule before the massage therapy and throughout the study
- could understand and communicate in Turkish
- Patients with an allergy to lavender oil
- had an open wound that would hinder the massage therapy
- had lower leg problems such as neuropathy
- had a neurological disease such as epilepsy, Alzheimer's disease, Parkinson's disease, or multiple sclerosis
- had a history of other CIT methods applied
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The study group massage therapy with lavender oil Each patient received the massage therapy with lavender oil on both lower legs for 10 minutes on each leg, for 4 weeks, three times a week, in the first half of the HD session (first 2 hours). The placebo control group massage therapy with baby oil Each patient received the massage therapy with baby oil on both lower leg areas for 10 minutes on each leg, for 4 weeks, three times a week, in the first half of the HD session (first 2 hours).
- Primary Outcome Measures
Name Time Method RLS Severity Rating Scale change from baseline score at the end of one month The RLS Severity Rating Scale was developed in 2003 by the International Restless Legs Syndrome Study Group. The scale was applied in the selection of patients and in the weekly evaluation of RLS severity. The scale comprised ten questions; each question was scored between 0 and 4. Questions 1, 2, 4, 6, 7, and 8 were related to RLS symptoms, questions 5, 9, and 10 were related to the effect of the disease on the mental state and daily social activities of patients with RLS, and question 3 was about the diagnostic criteria of RLS. The overall score indicated the RLS severity. A minimum score of 0 and a maximum score of 40 could be obtained. A score between 1 and 10 corresponded to "mild," 11-20 "moderate," 21-30 "severe," and 31-40 "very severe" RLS.
Kidney Disease Quality of Life Short Form (KDQOLTM-36) change from baseline score at the end of one month This scale is used in determining the quality of life of HD patients and those who have end-stage renal disease (ESRD) stages 1-5. The Turkish validity and reliability study of the scale was conducted by Yıldırım et al., with a Cronbach's alpha value of 0.84-0.91. KDQOLTM-36 is a personalized scale that includes general tests supported by multi-question scales targeting specific problems such as symptoms, effects of kidney disease on daily life, burden of the kidney disease, working status, cognitive functions, quality of social relations, sexual functions, and sleep among dialysis patients with kidney disease. Patients are asked questions based on the past month. The total and subscale scores were calculated based on the KDQOLTM-36 scoring program. Each item was scored using Likert's method. The scores range from 0 to 100, and higher scores indicated better health-related quality of life. "0" indicated the worst health status, whereas "100" indicated the best health status.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Internal Nursing, Faculty of Health Science, Erciyes University
🇹🇷Kayseri, Türkiye, Turkey